Clinical Research Glossary

investigational medicine investigational medicine


A treatment or drug that is not yet approved for the condition being studied.

Example of investigational medicine in a sentence

Being in a research study is one way a patient might have access to an investigational medicine.

More Info

Every country has health authorities or government agencies that review and approve studies of investigational medicines. They then use the study data on risks and benefits to decide whether the investigational medicine is safe and effective and whether it can be approved for the condition or purpose.

Other info to think about when joining a study

You may learn about an “investigational medicine” if you are thinking about joining a study that is looking at a treatment that is not yet approved. Your doctor or the study team may mention the investigational medicine in discussions or in the consent form.

You could ask the study team to explain more about why the investigational medicine is being studied. You may also want to ask about how the investigational medicine has been studied before and what the study objectives are.

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